Simvastatin in the treatment of idiopathic chronic pancreatitis
- Conditions
- Health Condition 1: K861- Other chronic pancreatitis
- Registration Number
- CTRI/2022/01/039260
- Lead Sponsor
- SIDS Hospital and Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
At screening, Adult patients ( >18 years of age, at the time of enrollment) with chronic pancreatitis (Cambridge grade 0 to III); and women of child-bearing potential having confirmed negative pregnancy test result prior to enrollment are eligible for the study.
1. If the patients had major ductal abnormalities (Cambridge Grade IV) or complications of chronic pancreatitis
2. If there will be any evidence of complete pancreas divisum either by MRCP or ERCP.
3. If there will be a history of active malignancy or pancreatic surgery or chronic myopathy
4. If patients were narcotic dependent or had previous exposure to HMG CoA inhibitor therapy
5. If the patient had family history of pancreatitis or pancreatic cancer
6. Pregnant or breast feeding women
7. If patient had any other reversible etiology such as alcohol, smoking, hypertriglyceridemia, autoimmune pancreatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Izbicki pain scoreTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Change in levels of Fecal ElastaseTimepoint: 6 months;Change in pancreatitis-related hospital readmissionsTimepoint: 6 months;Change in quality of life score as measured by the QLQ-C30 and QLQ-PAN28(CP)Timepoint: 6 months;Change in serum levels of CRP, IL-6, IL-10, TGF-�²1, <br/ ><br>MMP-9, TNF-�±, ands-fractalkine <br/ ><br>Timepoint: 6 months